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QSYMIA Drug Profile

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When do Qsymia patents expire, and when can generic versions of Qsymia launch?

Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has sixty patent family members in seventeen countries.

The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.

Summary for QSYMIA

International Patents:	60
US Patents:	10
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	8
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	QSYMIA at DailyMed

Pharmacology for QSYMIA

Drug Class	Sympathomimetic Amine Anorectic
Mechanism of Action	Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors
Physiological Effect	Appetite Suppression Increased Sympathetic Activity Decreased Central Nervous System Disorganized Electrical Activity

US Patents and Regulatory Information for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes			Y
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No			Y
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012		RX	Yes	Yes
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012		RX	Yes	No			Y

Expired US Patents for QSYMIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-001	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-002	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-004	Jul 17, 2012
Vivus	QSYMIA	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	022580-003	Jul 17, 2012

Paragraph IV (Patent) Challenges for QSYMIA

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Capsules	3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, 15 mg/92 mg		2013-07-18

Non-Orange Book US Patents for QSYMIA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,802,636	Combination therapy for treatment of sleep apnea

International Patents for QSYMIA

Country	Document Number	Estimated Expiration
Spain	2542891
Japan	2017078083
Israel	209875
World Intellectual Property Organization (WIPO)	2009152190